Multilevel HIV Prevention Strategy for Increasing PrEP Uptake

(STARR-NC Trial)

Overseen By Sarah E Rutstein, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: PrEP

Disqualifiers: HIV-positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new strategy to help people begin using PrEP, a medication that prevents HIV. It uses a digital health tool called HealthMpowerment, with some participants receiving additional support like a PrEP Navigator and telehealth services. The goal is to determine if these resources increase the number of people starting PrEP within three months of visiting a clinic. The trial seeks individuals who have been sexually active with a male in the past year, have recently tested negative for HIV, and are not currently using PrEP. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance PrEP uptake and improve public health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be currently using PrEP to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the HealthMpowerment Digital Health Intervention aims to increase the use of PrEP, a medication that helps prevent HIV. Although specific safety data for the app itself is not available, user input guided its creation to ensure it meets their needs. This suggests it is user-friendly and lacks significant reported risks.

PrEP, the medication central to this intervention, has FDA approval for preventing HIV in people at risk. Extensive research has shown that PrEP is safe and generally well-tolerated. Side effects are usually mild, such as nausea or headache, and often resolve over time.

The telehealth services offered through this intervention are also considered safe. Studies have shown that telehealth, which provides medical care through digital platforms, effectively delivers PrEP services. It has proven safe and effective for preventing HIV.

Overall, the different parts of this intervention, including PrEP and telehealth, have strong safety records based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new digital approach to increasing PrEP uptake among individuals at risk for HIV. Unlike traditional methods that rely solely on in-person consultations, this intervention leverages the HealthMpowerment digital health platform, offering enhanced features like interactive skill-building activities, a social support newsfeed, and anonymous health Q&A with experts. Additionally, the inclusion of a PrEP Navigator and Telehealth services aims to streamline access to PrEP, making it easier for participants to connect with necessary healthcare resources. This innovative, multi-faceted strategy could significantly improve how people access and adhere to PrEP, potentially reducing HIV transmission rates.

What evidence suggests that this trial's treatments could be effective for increasing PrEP uptake?

Research has shown that the HealthMpowerment Digital Health Intervention can help more people start using PrEP (pre-exposure prophylaxis). In this trial, participants in the intervention arm will receive an enhanced version of this digital tool, which uses mobile technology to connect with users and has shown promise in increasing PrEP use among men at risk. Additionally, PrEP navigation services, another component of the intervention arm, provide guidance from trained experts and are crucial in helping people begin and continue using PrEP. These services can reduce the risk of HIV by up to 99% when PrEP is taken correctly. Moreover, telehealth services for PrEP, also part of the intervention arm, have made it easier for people to access and adhere to their treatment plans. Together, these elements form a comprehensive approach to increase PrEP use and lower the risk of HIV. ^{3 4 6 7 8}

Who Is on the Research Team?

Sarah Rutstein, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals assigned male at birth, aged 18-39, who have had sexual activity with a male in the past year and are not currently using PrEP. They must speak English, have daily smartphone access, and have tested HIV-negative within the last 90 days.

Inclusion Criteria

Have daily smartphone access

Be English speaking

Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report

Exclusion Criteria

Confirmed prior HIV-positive diagnosis

I have used PrEP medication in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina STI clinics

3 years

Baseline and quarterly follow-up assessments

Intervention

Participants in the intervention arm receive a multilevel intervention including a PrEP Navigator, Digital Health Intervention platform, and referral to Telehealth PrEP services

6 months

Quarterly follow-up assessments

Control

Participants in the control arm receive standard PrEP referral services and a limited version of the Digital Health Intervention platform

6 months

Quarterly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Quarterly follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• HealthMpowerment Digital Health Intervention - Basic
• HealthMpowerment Digital Health Intervention - Enhanced
• PrEP Navigation Services
• Telehealth PrEP Services Referral

Trial Overview The study tests a strategy to increase PrEP use among participants. It includes randomized trials of PrEP Navigation Services, two versions of HealthMpowerment Digital Health Intervention (basic and enhanced), and Telehealth referrals over three years in rural North Carolina STI clinics.

How Is the Trial Designed?

Group I: STARR NC Intervention Condition Experimental Treatment 3 Interventions

Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care. The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement. Intervention Arm participants will complete baseline and quarterly follow-up assessments. Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

Group II: STARR NC Standard-of-Care Control Condition Active Control 1 Intervention

Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform. The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center. Control Arm participants will complete baseline and quarterly follow-up assessments. Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

HealthMpowerment Digital Health Intervention - Basic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Truvada for:

• HIV pre-exposure prophylaxis

Approved in United States as Truvada for:

• HIV pre-exposure prophylaxis

Approved in Canada as Truvada for:

• HIV pre-exposure prophylaxis

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A systematic review of literature from 2013-2014 identified 23 published studies and 32 funded projects utilizing eHealth and mHealth strategies to enhance HIV prevention and care, indicating a growing trend in using technology for health interventions.

Despite the effective use of social media and other digital tools in engaging populations for HIV prevention, significant gaps still exist in ensuring patients are linked to care, retained in care, and initiated on antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. Muessig, KE., Nekkanti, M., Bauermeister, J., et al.[2022]

A pilot study involving 16 HIV-negative men who have sex with men (MSM) demonstrated that a digital pill system (DPS) is a feasible and acceptable method for measuring adherence to daily PrEP, with 92.2% of expected ingestions recorded accurately.

The DPS showed strong correlations between recorded adherence and actual drug levels in the blood, indicating its effectiveness in tracking PrEP use, which is crucial for preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. Chai, PR., Mohamed, Y., Bustamante, MJ., et al.[2023]

A study involving 71 HIV-negative adults using a digital health feedback system with ingestible-sensor-enabled Truvada® showed that 88.7% of participants adhered to the medication for at least 28 days, with an average adherence rate of 86.2%.

Adherence patterns indicated that older age and negative methamphetamine screens were associated with better adherence, suggesting that substance use may negatively impact the effectiveness of oral PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. Browne, SH., Vaida, F., Umlauf, A., et al.[2023]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

Emerging technologies, such as internet and smartphone-based solutions, have the potential to significantly enhance HIV prevention efforts by reaching at-risk populations, particularly rural men who have sex with men (MSM), who are often underserved by traditional outreach methods.

A successful HIV prevention strategy should combine technology-enabled services with personalized interventions, ensuring that both algorithmic and non-algorithmic approaches are utilized to effectively meet the diverse needs of target populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging technologies for HIV prevention for MSM: what we have learned, and ways forward. Sullivan, PS., Grey, JA., Simon Rosser, BR.[2021]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

Mobile health (mHealth) tools have the potential to significantly enhance HIV prevention strategies among adolescent and young adult men who have sex with men (MSM), a group particularly at risk for new infections.

Despite the promise of mHealth interventions, challenges remain in integrating these tools into existing public health programs, necessitating strategies to overcome barriers to implementation and scale-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile apps for HIV prevention: how do they contribute to our epidemic response for adolescents and young adults? Sullivan, PS., Hightow-Weidman, L.[2021]

The ePrEP clinic, which offers online self-sampling for HIV and STIs, online consultations, and remote medication provision, was found to be highly acceptable among 15 PrEP users and 9 healthcare professionals, suggesting it could enhance convenience and empower users.

While the ePrEP clinic could increase capacity in sexual health services, some users expressed concerns about the need for blood self-sampling, indicating that it may be best suited for established PrEP users with good digital health literacy and no significant medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals. Kincaid, R., Gibbs, J., Dalrymple, J., et al.[2023]

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

The MyChoices mobile app, designed to increase HIV testing and PrEP use among young men who have sex with men (YMSM), was found to be highly acceptable and feasible, with 94% of participants using it at least once during the study.

In a pilot study with 60 participants, those using the MyChoices app showed a 22% higher prevalence of HIV testing compared to standard care, suggesting potential benefits, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and Acceptability of MyChoices: Results of a Pilot RCT of a Mobile App Designed to Increase HIV Testing and PrEP Uptake Among Young American MSM. Biello, KB., Daddario, SR., Hill-Rorie, J., et al.[2023]

To significantly reduce HIV incidence among men who have sex with men (MSM), a coverage of 40-50% for multiple primary prevention interventions, including preexposure prophylaxis, is necessary, but current coverage levels in the USA are insufficient.

Technology-based tools, such as mobile apps, have the potential to expand access to HIV prevention services for MSM, yet most existing apps are not specifically tailored for this population, highlighting a need for better-targeted solutions and sustainable funding to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Roles of Technology in Primary HIV Prevention for Men Who Have Sex with Men. Sullivan, PS., Jones, J., Kishore, N., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491899/

An mHealth App–Based Social Capital Intervention (PrEP US ... Secondary outcomes will include estimates of intervention efficacy in increasing PrEP uptake and decreasing condomless anal sex acts. Figure ...

2. nature.com nature.com/articles/s41746-025-01743-7

Real-time digital intervention on oral pre-exposure ... We evaluated the effectiveness of real-time digital intervention in promoting oral PrEP adherence through a randomized controlled trial using electronic ...

3. researchprotocols.org researchprotocols.org/2025/1/e68085/PDF

Protocol for a Randomized Controlled Trial Secondary effectiveness outcomes include PrEP uptake at 6 months, PrEP care engagement, PrEP use, PrEP adherence. [66-68], incident STIs ...

4. withpower.com withpower.com/trial/phase-hiv-pre-exposure-prophylaxis-7-2023-688a6

Multilevel HIV Prevention Strategy for Increasing PrEP ... The HealthMpowerment Digital Health Intervention is unique because it leverages mobile health (mHealth) technology to increase PrEP uptake among men who have ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825001477

Protocol Multilevel Intervention to Support Tailored and ... Our primary effectiveness outcome is PrEP uptake within 3 months of an STI clinic visit, defined as confirmed receipt of PrEP prescription or evidence of ...

6. healthmpowerment.org healthmpowerment.org/healthmpowerment-hmp-research-portfolio/

Digital Health Research Portfolio - HealthMpowerment (HMP) STARR-NC is a study to increase the uptake of PrEP (pre-exposure prophylaxis), medication that prevents HIV, within populations of young sexual minority men who ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11971580/

Protocol for a Randomized Controlled Trial - PubMed Central This protocol describes a randomized controlled trial of a multilevel PrEP intervention recruiting from rural and periurban STI clinics.

8. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-hiv-infections-2026-5b8a6

HealthMPowerment App for HIV Prevention The available research does not provide specific safety data for the HealthMPowerment App, but it does mention that the app was developed with input from users ...